Research conducted at The Hospital for Sick Children (SickKids) establishes promising safety and tolerability data for Tilray 2:100 oil for children with drug-resistant epilepsy (DRE) due to Dravet Syndrome

NANAIMO, BRITISH COLUMBIA – Tilray Inc., a global pioneer in medical cannabis production and distribution, is pleased to announce that a study featuring Tilray 2:100, a medical cannabis oil containing high amounts of cannabidiol (CBD) and conservative amounts of tetrahydrocannabinol (THC), has shown promising results for children with drug-resistant epilepsy (DRE) due to Dravet Syndrome. The findings of the Phase II trial, which was designed and conducted by researchers at The Hospital for Sick Children in Toronto (SickKids), were published today in the peer-reviewed medical journal Annals of Clinical and Translational Neurology.

“We are excited by the encouraging results of this study and the ability to already offer this highly concentrated CBD product to patients in Canada. We developed this product based on a strong existing evidence base that a combination cannabinoid product may have numerous benefits in this difficult to treat patient population,” said Catherine Jacobson, Director of Tilray’s Clinical Research Program. “In the participants who reached the target treatment dose there was a statistically significant reduction in motor seizures, and an increase in seizure-free days compared to those who did not reach the target dose. Promising clinically beneficial effects were observed, including a reduction in seizure frequency and improvements in certain aspects of adaptive functioning and quality of life measures.”

“This is an important study, providing valuable data about the safety and efficacy of a high CBD and low THC medication to treat Dravet syndrome, a disorder with high morbidity and mortality,” said Orrin Devinsky, MD, Chair of Tilray’s Medical Advisory Board and Director of the Comprehensive Epilepsy Center at New York University Langone Medical Center.

Tilray 2:100 contains the highest concentration of cannabis-extracted CBD in a medical cannabis product available through Canada’s Access to Cannabis for Medical Purposes Regulations (ACMPR). Tilray 2:100 has a target concentration of 100mg/ml CBD and 2mg/ml THC for a total cannabinoid amount of 4,000mg CBD and 80mg THC in each 40ml bottle.

Tilray 2:100 is available to pediatric patients through the ACMPR. As supply increases, the product will be made available to other patients in need. To help support access to this product, Tilray is proud to offer a discounted introductory price, as well as a compassionate pricing program based on financial need. For information on Tilray 2:100 and the compassionate pricing program, please call Tilray’s­ Patient Services team at 1-844-TILRAY1.

As the first study of its kind to examine with rigor the dosing and tolerability of a mixed cannabinoid product containing both CBD and THC in children with DRE due to Dravet Syndrome, these results set the foundation for further work to advance successful treatment and outcomes for this population of children who until now, had little hope for better health outcomes.

A limitation in this study concerns the small number of participants, the majority of whom were already taking a prescribed antiepileptic drug. Tilray donated product for the trial and funded the research. Next steps include additional research with more participants and variable doses of combined THC/CBD.

About Tilray®

Tilray is a global pioneer in the research, cultivation, production and distribution of medical cannabis and cannabinoids currently serving tens of thousands of patients in ten countries spanning five continents.